powerpoint presentation · 2019-05-19 · we need another smartwatch! fda*/ce* clearance for...
TRANSCRIPT
Why are we here?
Longer term: provide wrist-based hospital-grade diagnostics anywhere
Lead smart watch technology for LONG TERM, CONTINUOUS,COMFORTABLE monitoring of life-critical functions atMEDICALLY CERTIFIED SENSITIVITY AND SPECIFICITY LEVELS,in order to track:
Arrhythmia Atrial Fibrillation
BradycardiaTachycardia
Cardiac ArrestHeart Failure
Blood PressureSkin Temperature
Pulse RateRespiratory Rate
Oxygen SaturationBlood Glucose
Activity TrackingCalories Burned
Galvanic Skin ResponseMental StressSleep Analysis
Broad Health & Wellness
HEART CONDITIONS
VITAL SIGNS
WELL-BEING METRICS
Do we need another smartwatch or medical wearable?
Do we need another smartwatch or medical wearable?
FDA/CE
clearance for
medical
diagnostics
Continuousmeasurement
7/24
High reliability & accuracy in
motion
Long-term measurement
Comfortable and hassle-free
We need another smartwatch!
FDA*/CE*
clearance for
medical
diagnostics
Continuousmeasurement
7/24
High reliability & accuracy in
motion
Long-term measurement
Comfortable and hassle-free
Long-term monitoring is the only known effective solution for heart arrhythmias
*In process
Our value proposition
Our value proposition
Breakthrough and patent-protected sensor technologyto achieve:
Smartwatch technology combining state-of-the-art electronics, optics, mechanics and software algorithms to deliver a long-term, non-invasive solution
• Long-term, continuous, medically certifiable measurement accuracy levels for heart arrhythmia as well as vital signs in all day-to-day conditions
• Non-inflating, medically certifiable absolute blood pressuremeasurement
Four Unique & Proprietary
Technologies
Optical PPG with record accuracy, low false alarm rate and motion resistance
IP: 1 patent application
Optical PPG
Electronics cancelling ECG & PPG artifactsnoise emanating from finger movements
PPG
ACCELEROMETERS
ARTIFACT
Fingers movement
Accelerometers do not sense fingers movement
Artifact sensor detects movements very accurately
IP: 3 patent applications
Four Unique & Proprietary
Technologies
ECG & PPG artifact canceler
IP: 3 patent applications
Electro-mechanical sensor for blood pressure measurement over the radial artery
140
120
100
SYSTOLIC
80
70
60
0 600400200
DIASTOLIC
887 measurements | Mean error = 0.33 STD = 3.0
887 measurements | Mean error = 0.22 STD = 2.1
FDA requirements: Mean error < 5 mmHg STD = 8 mmHgmmHg = millimeters of Mercury
Four Unique & Proprietary
Technologies
Electro-mechanical sensor
Software algorithms for precise vitals measurement based on multi-sensors
Four Unique & Proprietary
Technologies
Software algorithms
Product Hardware
Blood Pressure
clip
Smartwatch
CardiacSense Smartwatch Connectivity Ecosystem
Patient Big Data & AI Analytics for early detection of critical events through digital health applications such as Apple HealthKitand Google Fit
CardiacSense Cloud
Offline data
Instantaneous Real-Time data in case of
event detection
Patient reports
Offline data Big Data & AI
Analytics Cloud
Offline (Full Disclosure)
and Real-Time (Event) data
Monitoring Center Cloud
Offline data Hospital Electronic
Medical Records Cloud
Real-Time data
Offline data
CardiacSenseWatch Cradle
Market Opportunity Atrial Fibrillation (AF) Detection
Regular pulse Atrial Fibrillation
The cost of AF-related strokes
(in the U.S.)
12$B
Long term monitoring is the only known
effective solution for heart arrhythmias
X5
AF increases the risk of stroke by 5x and
stroke severity by 5x (in the U.S.)
The leading technology for long-term AF diagnosis is invasive and costly
$
Source for $12B: Natale, A. &, Jalife, J (Eds). (2008) Atrial Fibrillation: From Bench to, (p. 13), NJ: Humana Press
DETECTION
DIAGNOSIS
MANAGEM
ENT
Addressable Market Size Atrial Fibrillation (AF) Detection
General Population Consumer wearables
High Risk AsymptomaticRisk factors: stroke, age,
hypertension, heart failure, diabetes, etc.
Symptomatic Initial Diagnostics
Post-AF ProceduresOngoing Management
U.S. Arrhythmia opportunity (Annual patients in millions)
DETECTION
DIAGNOSIS
MANAGEM
ENT
Addressable Market Size Atrial Fibrillation (AF) Detection
General Population Consumer wearables
High Risk AsymptomaticRisk factors: stroke, age,
hypertension, heart failure, diabetes, etc.
Symptomatic Initial Diagnostics
Post-AF ProceduresOngoing Management
U.S. Arrhythmia opportunity (Annual patients in millions)
Market Opportunity Blood Pressure (BP) Measurement
Hypertension is a cardiovascular condition that affects 75 million American adults
Pre-hypertension affects another 75 million American adults
46%
20%
Hypertension can lead to coronary heartdisease, stroke and even death.It is sometimes called the ”SILENT KILLER”
Do not have it under control
Not aware to be having this condition
51$B
Frequent monitoring is effective to detect hypertension and receive preventative medical treatment or a prescription medication
Current home blood pressure monitors are used occasionally, if at all. In addition, they are inflatable, subject to inaccuracies due to movement, position, time of day, size of blood pressure cuff, lack of calibration, “white coat syndrome” and patient error
Potential Business Models
Sales ofCardiacSense smartwatches
via distributors* to medical channels (subscription model): Hospitals, Assisted Living Centres, Mobile
Cardiac Outpatient Telemetry (MOCT) centers (e.g. CardioNet, Preventice Solutions)
*Distributors provide services of marketing, sales, logistics, regulatory, and legal. Manufacturing is outsourced to medically-certified partners
Sales ofBlood Pressure clips(to watch manufacturers)
Strategic partnership between CardiacSense and leading consumer wearables and/or medical equipment companies
SENSITIVITY / SPECIFICITY (DAY-TO-DAY CONDITIONS)
STILL ONLY CONDITION
20-40
40-60
60-80
80-100
SPOT CHECK SPOT CHECK EVERY 2 HRS.
< 2WEEKS < 1 MONTH < 3 YEARS
MO
NITO
RING
DURA
TIO
N
CONTINUOUS
CompetitionAtrial Fibrillation (AF) Detection
AlivecorFibricheck
Apple 4
iRhythm Zio
Medtronic Reveal Linq
Holter
CardiacSense
CompetitionBlood Pressure (BP) Measurement
Continuousas long as in a specific position
Once every 15 minfor a full day
Spot-check30-50 measurements
Spot-check200 measurements
+++Non-inflating
++Non-inflating
+Inflating cuff
inside a watch
-Inflating cuff
over the wrist
Heart arrhythmias,breathing rate -------- Heart rate Heart rate
$80 $198 $500 $100
CardiacSense BP clip HealthSTATS Bpro Omron HeartGuide Microlife wrist W100
Monitoring duration
Comfort level
Integration with other functionalities
Unit price
Eldad ShemeshChief Executive Officer
• Former VP Engineering, Spacecom• Former Head of satellite and space systems branch,
Israel Air Force• B.Sc., M.Sc. in Electrical & Electronics Engineering, Tel
Aviv University
Daniel NaorBoard Director
• Former McKinsey partner, Europe & North America• PepsiCo senior executive, North America• B.Sc., M.Sc. in Electrical Engineering & Computer
Science, M.I.T.• MBA, INSEAD European Business School
Prof. Boris SpectorOptics Design Leader
• Leading 20 electro-optical projects• PhD in Optics from Russian Academy of Sciences,
Siberian Branch – Novosibirsk• Senior Scientist and lecturer at the (EE) electrical
engineering faculty, Technion Israel
Prof. Sami ViskinChief Medical Officer (Arrythmia)
• Boston Scientific, Advisory Board• Director, Cardiac Hospitalization, Tel Aviv
Medical Center, Israel• Expert on atrial fibrillation• 140+ publications in peer reviewed journals• MD, Tel Aviv University, University of California
San Francisco
Prof. Giris JacobChief Medical Officer (Blood Pressure)
• Director, Internal Medicine, Tel Aviv Medical Center, Israel
• MD / PhD, Technion - Israel Institute of Technology
Liat ShemeshChief Operating Officer
• Experienced operations professional with strong start-up experience in high-tech companies
• B.Sc. in Chemistry, Tel Aviv University• M.Sc. in Chemistry, State University of New
York, Syracuse
• Former VP R&D, G Medical Innovations• B.Sc., Electrical (Electronic) Engineering, Technion -
Israel Institute of Technology• MBA, Tel Aviv University
Meni ItzhakVP Research & Development
Israel MakovSenior Advisor
• Former President & CEO, Teva Pharmaceuticals
• B.Sc. in Agriculture and an M.Sc. in Economics, the Hebrew University in Jerusalem
Team
The clinical trial includes
24 patientsbased on the following criteria
Completion of the first clinical trial is expected by March, 2019
96%or higher
Sensitivity
FDRFalse Discovery Rate
Correlation coefficient R
Regression line slope 1± 0.02
Bland-Altman 95% limits of agreement
Average (±tolerance) ± 1.96*SD: 0 (±5) ± 100
2%or lower
90%or higher
PPVPositive Predictive Value
80%or higher
The pass criteria for the clinical trial are
Skin color 2 each from Fitzpatrick skin types 5 and 6 (dark)
Age2 each from older than 65 and younger than 30
Body Mass Index 2 each from obese and underweight categories
Drivers4 patients that drive during trial
Hairiness level 4 patients with high level of hairiness level to assess light transmission
A-fib4 patients diagnosed with A-fib
First Clinical Trial for AF detectionby PPG and/or ECG for FDA Clearance
Roadmap
CURRENT
20192020-2021
2022Smartwatch beta version
Current (Non FDA)
A-FibCardiac Arrest HR HRV ECG
FDA & CE for A-FibFDA & CE BradycardiaFDA & CE Tachycardia
1st generation
FDA & CE Blood PressureFDA & CE Cardiac ArrestFDA & CE Respiratory RatePatient Big Data & AI Analytics
2nd generation
FDA approval for SPO2 over the wristFDA approval for Heart FailureGalvanic Skin ResponsePatient Big Data & AI Analytics
3rd generation
Smartwatch commercial version
Blood pressure clip commercial version Adding SPO2
sensorStrategic partnership options
26
MilestonesSuccessful finalization of preliminary trial for A-Fib
Successful finalization of pivotal trial for A-Fib
CE clearance for A-Fib
FDA clearance for A-Fib
Manufacturing of first batch of commercial watch
FDA clearance for Tachycardia and Bradycardia
FDA clearance for blood pressure
FDA clearance for breathing rate
2019 2020 2021Q 1 2 3 4 1 2 3 4 1 2 3 4
Finalization of clinical trial for FDA clearance of Blood Pressure
FDA clearance for Cardiac Arrest
Investment rounds and Sub-rounds
Amount raised ($K)
Pre-money valuation($K) Comment
2010-15 1,426 Shift to medical
2016May 2016 474 4,184 Private investors
December 2016 26 5,025 Private investors
2017
May 2017 200 5,225 AY Electronics Ltd.
June 2017 1,000 6,000 Public and private investors
October 2017 513 10,000 Public and private investors
2018March 2018 1,524 12,000 Public and private investors
December 2018 2,000 20,000 On going
Total 2016-2018 5,737
Grand total 2010 to date 7,163
Fundraising History to Date
Other sources of income
Source Amount ($K)
Israel Chief Scientist 292
Joint program with Korean Chief Scientist 300
NRE from different programs 150
Customer licensing 150
Total 892
CardiacSense Development Costs (in $K)2019 2020 2021 Total
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
G&A 187 202 226 241 256 256 256 286 286 286 2,482
R&D 635 659 738 738 738 738 738 738 738 738 7,197
Clinical 265 265 395 395 395 395 395 395 395 395 3,690
Commercial 112 127 150 165 175 195 199 199 199 199 1,720
SOM* Development 330 330 330 330 330 330 - - - - 1,980
Production of first 7,000 watches for clinical trials 100 100 100 100 100 100 100 100 100 100 1,000
Contingencies 100 100 100 100 100 100 100 100 100 100 1,000
Inflation @3%/year 61 62 63 63 109 111 111 111 691
1,729 1,783 2,100 2,131 2,157 2,177 1,897 1,929 1,929 1,929 19,760
Total Per Year 3,511 8,565 7,683
*System-on-Module 28
Strategic partnerships
Potential Strategic Partner and Estimated 2018 Sales of Their Devices Impact of CardiacSense technology
Apple $10B Smartwatches Premium pricing + additional volume
Samsung $2B Smartwatches Premium pricing + additional volume
Fitbit $1B Smartwatches Premium pricing + additional volume
Omron $1B Inflatable Blood Pressure Monitors Existing business substitution
Medtronic $1B Insertable Cardiac Monitors Existing business substitution
Example: Apple Watch premium of $100 over 30M units = $3B per year
Economics of CardiacSensesmartwatch to medical channel (subscription model)
2020 2021 2022 2023 2024
0 10 100 200 300
0 800 8,000 16,000 24,000
($0) ($200) ($2,000) ($4,000) ($6,000)
($1,843) ($2,032) ($2,811) ($3,671) ($4,533)
($1,843) ($1,432) $3,189 $8,329 $13,467
2020 2021 2022 2023 2024
Units (in K) 5 20 70 120 180
Cumulative Units (3 years) 5 25 95 210 370
Revenue (in $K) $1,400 $6,500 $24,100 $49,800 $84,600
Variable Costs ($500) ($2,000) ($7,000) ($12,000) ($18,000)
Fixed Costs ($6,723) ($6,381) ($8,313) ($11,060) ($14,722)
Profit ($5,823) ($1,881) $8,787 $26,740 $51,878
Economics of Blood Pressure clips to watch manufacturers
Smartwatch sales price $100 per unit
Subscription fee for 36 months minimum $15 per month
Smartwatch cost $100 per unit
Development costs increase after 2021 10% growth
Distributor support 10% of revenue
Blood Pressure clip sales price $80 per unit
Blood Pressure clip cost $20 per unit
30
In Conclusion • There is an unmet need for long-term medical monitoring of heart conditions (such as arrhythmia) and vitals (such as blood pressure)
• Current smartwatches do not provide such capabilities, despite the hype
• CardiacSense has a clinically proven technology to address these needs in a watch form-factor
• FDA and CE clearances for heart arrhythmias are expected by Q4, 2019
• FDA and CE clearances for blood pressure monitoring are expected by Q4, 2020
• Commercialization is expected to commence in H2, 2020
• Discussions with leading consumer wearable and medical equipment companies are ongoing
• We are seeking to raise $20M of funding to support this game plan
CardiacSense Apple Comments
Application AF detection Irregular rhythm suggestive of AF Apple not approved for AF detection due to low performance
Monitoring type Continuous Spot-check, once every 2 hours Apple constrained by high power consumption
Time to detect AF/irregular heart rhythm up to 5 minutes Up to 48 hours
Sensitivity 97% 79% Apple info submitted to the FDA
Specificity 97% 71% Apple research on the net
Operating time 4 days 1 day CardiacSense with System-on-Module has one month operating time per charge
Can monitor diagnosed AF patients Yes No Major issue for Apple as this is a 6 million people market in the US alone
Can detect finger movements Yes No Apple does not have the artifact sensor
Can detect Cardiac Arrest Yes No Apple does not have the artifact sensor
Medical device clearance Yes No Apple received the clearance for software in the cloud/mobile/watch only
36
Technical Performance Comparison
FDA Regulatory Strategy & TimelineCardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch
FDA clearance for AF detection by PPG and/or ECGTarget for clinical trials: Sensitivity = 100%, Specificity = 93%
▪ Following the Pre-Submission process, and successful clinical trials in 2016 at the Tel Aviv Medical Center in hospital conditions, the company has started its clinical trial for FDA approval through the DeNovo route. This consists of two clinical trials at ambulatory conditions:
• Preliminary trial: 24 people partitioned to 6 groups(Skin color, Age, BMI, Driving, Hairiness level, A-Fib)
▪ Primary endpoint: Beat by beat correlation between PPG and ECG ▪ Timeframe: trial will be completed on March 2019
• Pivotal trial: 100 people at one hospital in the US (Cleveland Clinic) andthree different hospitals in Israel
▪ Primary endpoint: AF detection▪ Timeframe: trial will be completed by July 2019
▪ CE mark is expected in Q3 2019, and FDA clearance is expected in Q4 2019▪ Subsequently, CardiacSense will conduct extensive clinical trials with Cleveland Clinic as well as
one of the biggest HMOs in Israel (Maccabi)• Over 1,000 people will be monitored for more than six months in a study focused on
health in the community▪ Primary endpoint: proving that CardiacSense system can reduce A-Fib treatment
cost, hospitalizations, and percentage of strokes▪ Timeframe: trial will be completed in 2020
FDA Regulatory Strategy & TimelineCardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch
FDA clearance for additional heart arrhythmias detection, such as Bradycardia and Tachycardia
• Results from preliminary clinical trial (beat to beat correlation)
will be used in this trial for detection of additional arrhythmias
• Expected clearance route: 510(k)
• Timeframe: 2020
FDA Regulatory Strategy & TimelineCardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch
FDA clearance for continuous measurement of absolute blood pressure
• During the past year CardiacSense has been collecting data at the
Tel Aviv Medical Center in a clinical trial to mature its technology
• Additional clinical trial will be conducted with 15 people in the US
• Expected clearance route: 510(k) (Tonometry)
• Timeframe: 2020
FDA Regulatory Strategy & TimelineCardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch